Farnier Michel, Roth Eli, Gil-Extremera Blas, Mendez Gustavo F, Macdonell Geraldine, Hamlin Constance, Perevozskaya Inna, Davies Michael J, Kush Debra, Mitchel Yale B
Point Medical, Dijon, France.
Am Heart J. 2007 Feb;153(2):335.e1-8. doi: 10.1016/j.ahj.2006.10.031.
Mixed hyperlipidemia is characterized by elevated low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and TG-rich lipoprotein levels.
In a multicenter, randomized, double-blind, placebo-controlled, parallel arm trial, eligible patients were 18 to 79 years of age, with mixed hyperlipidemia (LDL-C 130-220 mg/dL, TG 150-500 mg/dL). Patients with type 2 diabetes were limited to those with LDL-C of 100 to 180 mg/dL. Patients (N = 611) were randomized in a 3:3:3:1 ratio to one of 4 treatment arms for 12 weeks: ezetimibe/simvastatin 10/20 mg (EZE/SIMVA) + fenofibrate 160 mg (FENO), EZE/SIMVA 10/20 mg, FENO 160 mg, or placebo. The primary objective was to evaluate the LDL-C-lowering efficacy of EZE/SIMVA + FENO versus FENO monotherapy.
Low-density lipoprotein cholesterol level was significantly (P < .05) reduced with EZE/SIMVA + FENO (-45.8%) compared with FENO (-15.7%) or placebo (-3.5%), but not when compared with EZE/SIMVA (-47.1%). High-density lipoprotein cholesterol and apolipoprotein A-I levels were significantly increased with EZE/SIMVA + FENO (18.7% and 11.1%, respectively) treatment compared with EZE/SIMVA (9.3% and 6.6%) or placebo (1.1% and 1.6%), but not when compared with FENO (18.2% and 10.8%). Triglyceride, non-high-density lipoprotein cholesterol, and apolipoprotein B levels were significantly reduced with EZE/SIMVA + FENO (-50.0%, -50.5%, and -44.7%, respectively) versus all other treatments. Treatment with EZE/SIMVA + FENO was generally well tolerated with a safety profile similar to the EZE/SIMVA and FENO therapies.
Coadministration of EZE/SIMVA + FENO effectively improved the overall atherogenic lipid profile of patients with mixed hyperlipidemia. Clinical trial registry number: NCT 00093899 (http://www.ClinicalTrials.gov).
混合型高脂血症的特征是低密度脂蛋白胆固醇（LDL-C）、甘油三酯（TG）和富含TG的脂蛋白水平升高。
在一项多中心、随机、双盲、安慰剂对照、平行组试验中，符合条件的患者年龄在18至79岁之间，患有混合型高脂血症（LDL-C 130 - 220mg/dL，TG 150 - 500mg/dL）。2型糖尿病患者仅限于LDL-C为100至180mg/dL的患者。患者（N = 611）按3:3:3:1的比例随机分为4个治疗组之一，治疗12周：依折麦布/辛伐他汀10/20mg（EZE/SIMVA）+非诺贝特160mg（FENO）、EZE/SIMVA 10/20mg、FENO 160mg或安慰剂。主要目的是评估EZE/SIMVA + FENO与非诺贝特单药治疗降低LDL-C的疗效。
与非诺贝特（-15.7%）或安慰剂（-3.5%）相比，EZE/SIMVA + FENO组的低密度脂蛋白胆固醇水平显著降低（P <.05）（-45.8%），但与EZE/SIMVA（-47.1%）相比无显著差异。与EZE/SIMVA（分别为9.3%和6.6%）或安慰剂（分别为1.1%和1.6%）相比，EZE/SIMVA + FENO治疗组的高密度脂蛋白胆固醇和载脂蛋白A-I水平显著升高（分别为18.7%和11.1%），但与非诺贝特（分别为18.2%和10.8%）相比无显著差异。与所有其他治疗相比，EZE/SIMVA + FENO组的甘油三酯、非高密度脂蛋白胆固醇和载脂蛋白B水平显著降低（分别为-50.0%、-50.5%和-44.7%）。EZE/SIMVA + FENO治疗总体耐受性良好，安全性与EZE/SIMVA和非诺贝特疗法相似。
EZE/SIMVA + FENO联合用药有效改善了混合型高脂血症患者的整体致动脉粥样硬化血脂谱。临床试验注册号：NCT 00093899（http://www.ClinicalTrials.gov）。
